Western Drug Recalls Hydroxocobalamin Injection Due to Sterility Risk
Western Drug recalls all lots of Hydroxocobalamin 5000IU/mL Injection due to lack of assurance of sterility. Nationwide distribution.
Use caution until it’s fixed
Lack of Assurance of Sterility
Contact the company
What happened, in plain English
Western Drug has recalled all lots of its Hydroxocobalamin 5000IU/mL Injection because there is a lack of assurance of sterility. This Class II recall affects products distributed nationwide across several states including Arizona, California, and Texas. The record does not specify the exact remedy or deadline for this recall. Read more at govinfonow.com/recall/43426-western-drug-recalls-hydroxocobalamin-5000iu-ml-injection-rx-western-drug.
Source Summary by GovInfoNow · govinfonow.com/recall/43426-western-drug-recalls-hydroxocobalamin-5000iu-ml-injection-rx-western-drug · Updated October 11, 2026 · FDA enforcement record: FDA #D-0410-2016
Cite this page
“Western Drug Recalls Hydroxocobalamin Injection Due to Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43426-western-drug-recalls-hydroxocobalamin-5000iu-ml-injection-rx-western-drug. Based on FDA recall #D-0410-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0410-2016%22&limit=1).
Why it’s dangerous
The product lacks assurance of sterility, which means it may be contaminated with microorganisms. Injecting a non-sterile product can lead to serious infections or other complications at the injection site or systemically.
Who’s affected
Patients who have received or possess Hydroxocobalamin 5000IU/mL Injection from Western Drug Inc., particularly those in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah.
How to tell if you have this one
Look for Hydroxocobalamin 5000IU/mL Injection manufactured by Western Drug Inc., located at 106 E. Main Street, Springerville, Arizona 85938. The recall covers all lots of this product.
- Brand
Western Drug- Category
Drug
All 91 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0394-2016 | Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 16 containers |
| D-0395-2016 | Ace-Promazine 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0396-2016 | AMP50/B121MG Complex Mix/ML Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 4 containers |
| D-0397-2016 | B-12 1000/B6 1000 mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0398-2016 | Bladder Mixture Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 4 containers |
| D-0399-2016 | Boric Acid 1% Ear Drop, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 2 containers |
| D-0400-2016 | Butor/Nal/Hydro Nasal Susp, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 2 containers |
| D-0401-2016 | Cyclosporine 1% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 4 containers |
| D-0402-2016 | Dep-Estradiol 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 9 containers |
| D-0403-2016 | Depo-Testadiol 10/5mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 4 containers |
| D-0404-2016 | Folic Acid Injection 5 mg/mL,10 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 8 containers |
| D-0405-2016 | Furosemide 20 mg/mL svn Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0406-2016 | Gent 80 mg/Liter Nasal, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0407-2016 | Glutathione 200 mg/mL SVN Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0408-2016 | Glutathione 300 mg/1.5 mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0409-2016 | Hydroxocobalamin 1mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 3 containers |
| D-0410-2016 | Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 2 containers |
| D-0411-2016 | M-Cobalamin (B12) Injection 200 mcg, 2000mcg, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 3 containers |
| D-0412-2016 | M-Cobalamin 2/Folate 5mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 2 containers |
| D-0413-2016 | Medroxyprogesterone 150/LID 5 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 17 containers |
| D-0414-2016 | Methylcobalamin Injection 1000 mcg/mL, 10000 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 46 containers |
| D-0415-2016 | Methylcobalamin Injection 10 mg/mL, 20 mg/mL, 30 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 34 containers |
| D-0416-2016 | Mupiro/Doxycyc Sinus Rinse, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 2 conatiners |
| D-0417-2016 | Alcohol4%/Bupivicaine0.5% sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 3 containers |
| D-0418-2016 | Ascorbic Acid 500 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 6 containers |
| D-0419-2016 | Cantharitus Multi-Mix Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0420-2016 | Benadryl 50mg/2mL Pres-Free Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0421-2016 | Calcium Chloride Dihydrate Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0422-2016 | Calcium EDTA 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 2 containers |
| D-0423-2016 | Calcium Gluconate 10% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 2 containers |
| D-0424-2016 | Cantharidin 0.7% Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0425-2016 | Cyancobalamin 2000mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 5 containers |
| D-0426-2016 | Dexpanthanol B5 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 4 containers |
| D-0427-2016 | Dextrose 50% Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0428-2016 | HCG 10,000U/10mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona; all lots | 8 container |
| D-0429-2016 | Heparin 1000 Unit/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 2 containers |
| D-0430-2016 | Heparin Sodium 30,000U/30ML Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0431-2016 | Hydrochloric Acid 2mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 2 containers |
| D-0432-2016 | Jessners Dermal Solution, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0433-2016 | Ketorolac 40mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0434-2016 | Lidocaine Injection 1% , 2%, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 4 containers |
| D-0435-2016 | Magnesium Chloride Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 2 containers |
| D-0436-2016 | Magnesium Sulfate 50% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 4 containers |
| D-0437-2016 | Marcaine 0.24%/Ethanol 4% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 5 containers |
| D-0438-2016 | N.A.C. 20% SVN Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0439-2016 | Novarel "HCG" 10000U/Vial, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 vial |
| D-0440-2016 | Omnitrope 17.4U/10mL Inj-Kit, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 18 containers |
| D-0441-2016 | Phenylephrine 500mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0442-2016 | Podophyllum 40% Topical, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0443-2016 | Potassium Chloride 40 mEq/mL Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 2 containers |
| D-0444-2016 | Procaine HCl Injection 1%, 2%, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0445-2016 | Progesterone Cyp Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0446-2016 | Pyridoxine B6 100mg Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 3 containers |
| D-0447-2016 | PZI 40 Insulin (Human) Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 9 containers |
| D-0448-2016 | Quad Mix Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 15 containers |
| D-0449-2016 | Sal-Acid 60% Plaster Paste, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0450-2016 | Sermorelin Injection 10mg/10mL,10mg/mL, 20mg/10mL, 9mg/9mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 45 containers |
| D-0451-2016 | Serum Tears 20% Opth, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 3 containers |
| D-0452-2016 | Sodium Bicarbonate 8.4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 4 containers |
| D-0453-2016 | Squaric Acid 4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0454-2016 | Super B Comp w/Cyano 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 15 containers |
| D-0455-2016 | T.C.A 30% Acid Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0456-2016 | Tacrolimus 0.02% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 2 containers |
| D-0457-2016 | Test Cyp/Test Prop 1:1 Injection 100mg/mL, 120mg/mL, 150mg/mL, 160mg/mL, 170mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 75 containers |
| D-0458-2016 | Testost CYP 200mg/mL SUS, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 2 containers |
| D-0459-2016 | Testosterone Injection 100mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 39 containers |
| D-0460-2016 | Tev-Tropin (Somatropin) Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 6 containers |
| D-0461-2016 | Toradol 60mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0462-2016 | Testosterone CYP Inj 200 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0463-2016 | Tri-Amino OAC 1:1:1 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 36 containers |
| D-0464-2016 | Tri-Mix ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 68 containers |
| D-0465-2016 | Tri-Test 1:1:1 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 3 containers |
| D-0466-2016 | Verapamil 120mg/12mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0467-2016 | Vitamin B12 (Cyan) Inj 100mcg/mL, 1000mcg/mL, Rx Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 8 containers |
| D-0468-2016 | Vitamin B-Complex 100 Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 7 containers |
| D-0469-2016 | VitB12/VitC/VitB3/VitB9 Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 4 containers |
| D-0470-2016 | Wilson's Nasal Irrigation Solution, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 2 containers |
| D-0471-2016 | Hydroxocobalamin 1mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 2 containers |
| D-0472-2016 | 17-Hydroxyprogesterone 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 41 containers |
| D-0473-2016 | Sodium Chloride 0.9% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0474-2016 | Sodium Hydroxide 10% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0475-2016 | HCG 1000unit/10mL MTU vial, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 3 vials |
| D-0476-2016 | Lipodissolve 100/50mg Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0477-2016 | Super B Complex 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0478-2016 | Super B Complex w/Cyano Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 4 containers |
| D-0479-2016 | Tacrolimus 0.03% Opth Oint, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 3 containers |
| D-0480-2016 | Triamcin 40mg/mL Susp, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 2 containers |
| D-0481-2016 | Triamcin40/Lido5 mg/mL Sus, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 16 containers |
| D-0482-2016 | Tri-Mix LOW ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0483-2016 | Quad Mix Strong Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
| D-0484-2016 | Salicylic Acid Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots | 1 container |
What to do — step by step
Check Your Inventory
Verify if you have Hydroxocobalamin 5000IU/mL Injection from Western Drug Inc., as all lots are included in this recall.
Consult Healthcare Provider
Contact your healthcare provider or pharmacist for guidance on what to do with the recalled product, as the specific remedy is not stated in the record.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
FDA distribution: “Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, Utah.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0410-2016 (October 19, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0410-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.